SOP to Lead Research Effort to Find Methods Engaging Hard-to-Reach Patients

A new Congressionally established research institute has asked the University of Maryland to help find ways to include hard-to-reach patients in research design and implementation.

By Steve Berberich
January 30, 2012

Through a unique contract from the Patient Centered Outcomes Research Institute (PCORI), the University of Maryland (UM) Schools of Pharmacy, Medicine, and Nursing aim to show the nation how more effectively to include hard-to-reach patients, who often have multiple medical problems, in health care decision-making.

PCORI is an independent agency established by the federal Affordable Care Act of 2010 as a non-governmental, non-profit organization. The Institute’s goal is to help patients, their caregivers and clinicians make better-informed health care decisions by supporting the development of trusted, high-quality, useful information on options for prevention, diagnosis and treatment of diseases and conditions.

“The contract, awarded to the School of Pharmacy, is one of only a few PCORI contracts issued to date for developing models, protocols, or guidelines for including patients in research design and implementation.

“Our contract is very ambitious, focusing on those patients who are least likely to be engaged in research, such as racial and ethnic minorities, patients who are of a low socio-economic status, and patients with some type of impairment, including visual, hearing, mobility, or cognitive,” says principal investigator C. Daniel Mullins, PhD, a professor of pharmaceutical health services at the School of Pharmacy. “Researchers usually don’t outreach to such patients because it takes more time and effort to include them.”

According to a statement by Joe Selby, MD, MPH, executive director of PCORI, the mission of PCORI is to provide “evidence on the effectiveness, benefits, and harms of different treatment options for different patients from studies that compare drugs, medical devices, tests, surgeries or ways to deliver health care.”

The Mullins team, including researchers from the UM Schools of Medicine and Nursing , will be utilizing focus groups to gather opinions of the various hard-to-reach patient populations and the individuals who care for them. These patient and caregiver focus groups will occur in Baltimore, which is also the home of the three UM schools involved.

Mullins notes that PCORI likely chose Baltimore because of the rich history of community activism by health care and social work leaders from the University of Maryland and other universities in the city.

“I personally think that this is the way that research should be done,” he says. “Science can tell us how people might respond to treatment genetically, but basic sciences cannot predict behavior. We need to understand how patients think and how they behave based on their preferences, not just their genetics. Only when we listen to patients’ experiences and concerns are we going to help them make wise decisions about medical treatments.”

The team will reach out into communities with the help of several partners, including the research and statistical survey firm Westat, Inc. of Rockville, MD; Bon Secours Health System; the Association of Black Cardiologists; and the Mt. Lebanon Baptist Church.

By early March 2012, Mullins and his team will provide a report to PCORI that provides guidance for how other research teams can best conduct research with hard-to-reach patients and their caregivers